Device for packaging and folding a flexible material part, in particular a parietal reinforcement

ABSTRACT

The invention concerns a device comprising: a packaging box for the flexible material part, dimensioned to hold said part flat; folding means for folding said part without direct handling; and a reception tube for receiving said folded flexible material part. The invention is characterized in that the reception tube is not longitudinally slit, and the folding means comprise; a traction suture connected to the flexible material part, which passes through the tube, and, walls forming a funnel whereof the base emerges proximate to the opening of the tube through which the flexible material part is designed to be inserted into said tube, said funnel being designed, when a traction is exerted on the traction suture, to gradually fold down the zones of the part located laterally relative to the tube towards the zone of the part located opposite the opening of said tube, to enable the part to be inserted into the tube.

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention relates to a device for packaging and folding aflexible material part, especially a parietal reinforcement.

2. Background of Related Art

Certain flexible material parts have to be stored flat in theirprotective packagings in order to avoid any alteration of their flatshape following prolonged folding or rolling up, in particular theformation of creases, then, at the point of use, have to be foldedlongitudinally or rolled up in such a way as to have a compactcross-sectional shape.

This is particularly the case with a parietal reinforcement designed tobe fitted by means of a coelioscopy method. The reinforcement must, infact, be arranged flat in its packaging, otherwise irreversible creasesmight be formed in its material, subsequently preventing thereinforcement from being placed in intimate contact with the wall to betreated, with a view to a cell colonization. At the moment of itsimplantation, the reinforcement must be folded for insertion into atrocar so as to be introduced into the body of the patient through asmall orifice.

According to an existing method, the reinforcement is simply placed in aparallelepipedal box of suitable dimensions. This box is opened at themoment of the fitting of the reinforcement and the practitioner foldsthis reinforcement manually prior to inserting it into a previouslyfitted trocar.

This method has the drawback of involving a handling of thereinforcement and hence of generating a risk of its becomingcontaminated by the gloves of the practitioner. Moreover, thereinforcement rubs against the wall of the trocar as it is inserted intothe latter, which likewise risks contamination of the reinforcement ifthe wall of the trocar is contaminated.

French patent No. 94/12700 proposes inserting a traction suture throughthe reinforcement, along a crenellated or wavy path. Pulls on the endsof the suture allow a “concertina-type” folding of the reinforcement tobe achieved.

This method has the advantage of avoiding direct handling of thereinforcement for achievement of the folding, of ensuring a minimum bulksize of the reinforcement prior to introduction into the trocar, and ofproducing a concertina-type folding, which allows the reinforcement tobe unfolded as it is extracted from the trocar. On the other hand, thismethod still involves handlings of the reinforcement at the moment ofcollection from its packaging box and its introduction into the trocar.Nor does this method eliminate the risk of contamination of thereinforcement by rubbing against the wall of the trocar.

Another method likewise consists in equipping the packaging box of thereinforcement with a roll-up key connected to one of the edges of thereinforcement and with a longitudinally slit tube into which the roll-upkey is placed. At the moment of fitting of the reinforcement, the key isrotated, enabling the reinforcement to be rolled up and engaged in theslit tube. This slit tube is used to introduce the reinforcement intothe trocar.

This method has the advantage of eliminating all handling of thereinforcement during folding and of protecting the reinforcement fromall contamination by rubbing against the wall of the trocar. On theother hand, the slit in the tube has the drawback of making the trocarnon-impervious to gas when this tube is engaged through the valveprovided in the proximal end of the trocar. The result is that, upon theinsertion of this tube into the trocar, there is an escape of the carbondioxide used to raise the abdominal wall of the patient in order to freethe zone of implantation of the reinforcement. The latter has thereforeto be introduced “blind”, which is undoubtedly a constraint. The slittube, moreover, has a relatively large outer diameter, 12 mm in size,resulting from the use of the roll-up key. This large diameter entailsthe use of a trocar of corresponding inner diameter, not always suitedto the surgical conditions. In addition, the reinforcement is rolled upupon itself, such that it has to be fully released from the trocar inorder to be able to be opened out at the implantation site; this releaseis a marked constraint as compared to a concertina-type folding asmentioned above, which allows the reinforcement to be opened out as itis extracted from the trocar.

The present invention aims to eliminate precisely these drawbacks.

SUMMARY

The device concerned comprises, in a manner which is known per se:

a packaging box for the flexible material part, dimensioned so as tohold this part flat,

folding means allowing this part to be folded without direct handling,and

a receiving tube, designed to receive the flexible material part in thefolded state.

According to the invention,

the receiving tube is not longitudinally slit, and

the folding means comprise:

-   -   a traction suture connected to the flexible material part, which        passes through the tube, and    -   walls forming a funnel, the base of which emerges close to the        opening in the tube through which the flexible material part is        designed to be introduced into this tube, this funnel being fit,        when a traction is applied to the traction suture, to        progressively fold down those zones of the part which are        situated laterally relative to the tube toward that zone of the        part which is situated opposite the opening in this tube, to        allow the part admission to the tube.

The engagement of the flexible material part in the tube is thusrealized by simple traction on said traction suture, hence without anydirect contact or handling of this part. The funnel-forming walls causethose zones of the part situated laterally relative to the tube to befolded toward that zone of the part which is situated opposite theopening in this tube and therefore allow the achievement of a more orless “concertina-type” folding-up of this part in this tube.

The packaging and folding device can be produced with standard materialsfor a packaging, at very low cost price. It can especially be producedby the assembly of parts made of thermoformed synthetic material.

The flexible material part, once inserted in the tube, is perfectlyprotected from contaminations upon its introduction into a trocar. Thistube forms, moreover, a particularly convenient means for achieving thisintroduction in optimal conditions. The tube can have a relatively smalldiameter, especially eight millimetres, which allows it to be used withtrocars of corresponding small diameters; it thus avoids recourse to aspecial trocar in order to realize said introduction, therebysubstantially simplifying the operation. Furthermore, since it is notslit, the tube is gas-tight and does not give rise to an escape ofcarbon dioxide when introduced through the valve fitted to the trocar.

This tube, moreover, can itself be equipped with a proximal gas-tightvalve and can, therefore, itself be used as a trocar. This possibility,apart from the simplification which it brings, helps to reduce the costof the procedure.

Advantageously, said funnel-forming walls comprise two rounded wallsdefining between them a pass-through gap for the flexible material parthaving a width less than that of this opening in the tube.

These rounded walls prove to allow the flexible material part to befolded up perfectly. They can especially be constituted by side walls oftwo cylindrical blocks connected to the packaging box.

The flexible material part could, in this box, extend in the horizontalextension of the tube, which would have the drawback, however, ofconferring large dimensions upon the device and of involving an increasein material. For this reason, according to a preferred embodiment of theinvention, the device comprises a tray which delimits, with thepackaging box, a bottom receptacle for receiving the flexible materialpart, comprises said funnel-forming walls on its face opposite thatdelimiting this receptacle, and has a rounded side edge, extending backfrom the box, around which the flexible material part is designed toslide when the aforesaid traction is applied to the traction suture.

This tray can comprise wedging means allowing the receiving tube to beimmobilized until the flexible material part is fully engaged in thistube.

Advantageously, the device additionally comprises a cover configuredsuch as to grip the receiving tube tightly between it and the aforesaidtray.

This cover, in conjunction with the tray, allows the receiving tube tobe perfectly immobilized throughout the operation for inserting theflexible material part in this tube.

This cover can be separable from said tray to allow extraction of thereceiving tube. Preferably, it comprises a hinged flap, allowing accessto the receiving tube with a view to such extraction.

Advantageously, said tray or said cover, or both, can comprise a zone inthe shape of an inverted “V”, the base of which is situatedsubstantially coaxially to the axis of said receiving tube, this zonebeing designed to be passed through by the traction suture.

This zone thus allows that portion of the traction suture which isengaged in the receiving tube to be held perfectly coaxial to this tube,whatever the angle at which the traction is applied to this suture.

For a good understanding thereof, the invention is re-described belowwith reference to the appended diagrammatic drawing representing, by wayof non-limiting example, a preferred embodiment of the device to whichit relates.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of the parts which make it up,prior to configuration of one of these parts with a view to itsassembly;

FIG. 2 is a view, similar to that of FIG. 1, of these same parts, aftersaid configuration;

FIG. 3 is a side view of the device, in longitudinal section;

FIG. 4 is a sectional view along the line IV-IV of FIG. 6;

FIG. 5 is a top view during folding of a parietal reinforcement which itcontains; and

FIG. 6 is a view similar to FIG. 5, after this parietal reinforcementhas been fully folded.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGS. 1 to 4 represent a device 1 for packaging and folding a parietalreinforcement 2, this reinforcement 2 being designed to be fitted bymeans of a coelioscopy method.

The reinforcement 2 is of the traditional type, especially realized inthe form of a woven fabric or a knitted fabric of synthetic fibres, withopenwork structure. In the example represented in the drawing, it has asubstantially rectangular general form, such that it defines an end sideedge 2 a having a medial zone.

The device 1 comprises a packaging box for the reinforcement 2, a tray3, a receiving tube 4 for receiving the reinforcement 2 in the flatstate, a cover 5 and a traction suture 6. A second supplementarypackaging box (not shown), receiving the whole of the device 1, may beprovided so as to ensure the perfect sterility of the device.

The packaging box for the reinforcement 2 is formed by a base 7 and alid 8.

The base 7 comprises side walls 10 delimiting a cavity 11 and an outerperipheral rim 12 situated level with the opening in the cavity 11.

The lid 8 is sealed on the rim 12 such that it can be peeled off.

The cover 5 is constituted by a part made of thermoformed syntheticmaterial. It has walls 15, allowing it to be fitted tightly into theopening in the base 7, and a peripheral rim 16, designed to come to bearagainst the rim 12 upon completion of this fitting.

The cover 5 is sub-divided into a main portion 5 a and a marginalportion 5 b, the latter being connected to the main portion 5 a along atransverse fold line 17. This line 17 forms a hinge, which allows theportion 5 b to be folded upward relative to the portion 5 a.

The portion 5 a has six oblong blocks 18 and two cylindrical blocks 19delimiting, on the bottom face of the cover 5, cavities designed totightly receive corresponding respective blocks 42, 46 (cf. FIGS. 2 and3), contained in the tray 3, so as to allow the assembly of the cover 5and of the tray 3.

This portion 5 a likewise has an elongate depression 20, which delimitsa semi-cylindrical receptacle emerging on the bottom face of the cover5, this receptacle being designed to tightly receive the tube 4, asshown in FIGS. 3 to 6. On the side opposite the portion 5 b, the portion5 a has a raised wall 21.

The portion 5 b has a boss 25 delimiting, on the bottom face of thecover 5, a receptacle designed to receive a widened proximal portion 4 aof the tube 4. This boss 25 is bounded, on the side opposite the portion5 a, by a wall 26 perpendicular to the axis of the receptacle delimitedby the depression 20 (cf. FIG. 3).

This portion 5 b additionally has side cavities 27 and, on the sideopposite the portion 5 a, two rounded zones which delimit cavities 28.These cavities 27 and 28 are fit to receive the fingers of a user, aswill become apparent later.

In addition, as shown by FIG. 4, the portion 5 b has, on the sideopposite the portion 5 a, a notch 29 in the form of an inverted “V”, thebase of which aligns substantially with the axis of the receptacledelimited by the depression 20 when the portion 5 b is placed in theextension of the portion 5 a.

The tray 3 is likewise made of a thermoformed synthetic material. It hasa main portion 3 a and a marginal portion 3 b mutually connected by atransverse fold line 35. This line 35 allows the portion 3 b to befolded over onto the portion 3 a, as can be seen by comparing FIGS. 1and 2. This line 35 is bordered by two grooves having rounded bases,such that the folding-over of the portion 3 b onto the portion 3 a formsa relatively broad rounded flange 36.

It can be seen in FIGS. 1 and 2 that the portions 3 a and 3 b haveblocks 34 and corresponding recesses 38, as well as ribs and snap-lockdepressions 39, which allow the tight fitting and retention of theportion 3 b on the portion 3 a.

The portion 3 a has a peripheral rim 37, which allows it to bepositioned, with wedging, in the base 7. This portion 3 a is dimensionedin such a way that the flange 36 is located back from the correspondingwall 10 of the base 7. When the tray 3 is placed in the base 7, apassage 40 therefore exists between this flange 36 and this wall 10, fitto allow the reinforcement 2 to slide through it.

The portion 3 a comprises a raised central zone 41, defining a bottomreceptacle for receiving the reinforcement 2. This zone 41 comprisesfour blocks 42, a semi-cylindrical receptacle 43 emerging in the topface of the tray 3, dimensioned so as to tightly receive the tube 4, aflared receptacle 44 dimensioned to tightly receive the portion 4 a ofthe tube 4, and two cavities 45 designed to receive the walls delimitingthe cavities 27.

For its part, the portion 3 b comprises two blocks 42 and twocylindrical blocks 46, as well as a semi-cylindrical depression 47 whichdelimits a receptacle entering the extension of the receptacle 43 whenthe portion 3 b is folded over onto the portion 3 a. This receptacle isfit, with the receptacle delimited by the depression 20, to tightlyreceive the tube 4, as is shown by FIG. 2.

It can be seen, more particularly in FIGS. 5 and 6, that the two blocks46 are arranged at a distance apart less than the inner diameter of thetube 4, such that they form a stop against which the end of the tube 4comes to be positioned when this tube 4 is placed in the aforesaidreceptacles of the tray 3 and cover 5. FIGS. 3 and 5 show, for theirpart, that the length of the tube 4 is such that the other end of thistube 4 reaches the immediate proximity of the wall 26. This tube 4 isthus tightly imprisoned between the cover 5 and the tray 3 when theblocks 42 and the top part of the blocks 46 are engaged in the cavitiesdelimited by the blocks 18 and 19 and is axially jammed when the portion5 b is held applied to the tray 3. The raising of this portion 5 ballows, on the other hand, the removal of the step formed by the wall26, so that the tube 4 can be withdrawn, by sliding, from between thecover 5 and the tray 3.

The portion 4 a of the tube 4 accommodates a gas-tight shutter, of thetraditional type. This shutter is fit to resist the pressure of thecarbon dioxide gas used to raise the patient's abdominal wall during theprocedure, which raising offers freedom of access to the site ofimplantation of the reinforcement 2.

The suture 6 comprises two strands forming a loop. It is connected tothe medial zone of the aforesaid side edge 2 a of the reinforcement 2and passes through the tube 4. Its length is such that it can be graspedin order to apply a traction capable of making the reinforcement 2penetrate the tube 4, as described below.

In practice, the user grasps the suture 6 by one hand and, with hisother hand, applies pressure to the portion 5 b, engaging his thumb andhis index finger of this other hand in the cavities 27.

A traction is applied to the suture 6, causing the reinforcement 2 topass around the flange 36 before coming into contact with the side wallsof the blocks 46. This contact, as illustrated in FIG. 5, produces agradual folding-down of the side zones of the reinforcement 2 toward themedial zone of this reinforcement, and hence a more or lessconcertina-type folding of the reinforcement 2.

Continuation of this traction effects the complete introduction of thereinforcement 2 into the tube 4.

In the course of this traction, the suture 6 comes to bear against thebase of the notch 29, thereby ensuring that the portion of the suture 6situated in the tube 4 is held in a position substantially coaxial tothis tube 4, whatever the angle at which the user applies said traction.

Once the reinforcement 2 is fully engaged in the tube 4, the cavities 28are utilized to raise the portion 5 b of the cover 5 and thus free thetube 4, which is able to be withdrawn, by sliding, from between thecover 5 and the tray 3.

The tube 4 can then be used as a trocar for introducing thereinforcement 2 into the body of the patient.

As is evident from the above-stated, the invention provides a device forpackaging and folding a flexible material part, especially a parietalreinforcement 2, which device offers the following decisive advantages:

“concertina-type” folding of the reinforcement 2, without any manualcontact with the reinforcement and according to a simple movement;

insertion of the reinforcement 2 into a tube 4 of relatively smalldiameter, allowing the reinforcement to be protected as it is fedthrough a trocar;

gas-impermeability of the tube 4 and possibility of use of this tube asa trocar;

possibility of producing the device with standard packaging materials,at a very low cost price.

The invention is not, of course, limited to the embodiment describedabove by way of example, but instead embraces all the constructionvariants within the scope of the protection defined by the attachedclaims.

1. A device for packaging and folding a flexible material part,comprising: a base dimensioned for receiving the flexible material partin a planar configuration, a receiving tube, configured to receive theflexible material part in a folded state; the receiving tube having aproximal opening and a distal opening, and defining a lumen therethroughalong a longitudinal axis, and a folding mechanism including: a sutureconnected to the flexible material part, and a funnel positionedadjacent to the distal opening of the receiving tube, the funnel beingconfigured to fold the flexible material part for passage of theflexible material part into the receiving tube.
 2. The device as claimedin claim 1, wherein the receiving tube includes a proximal gas-tightvalve.
 3. The device as claimed in claim 1, wherein the funnel comprisesat least two spaced apart walls defining a gap therebetween configuredto receive the flexible material part, the gap having a width less thanthe width of the distal opening the receiving tube.
 4. The device asclaimed in claim 3, wherein the at least two walls are formed by atleast two side walls of at least two cylindrical blocks connected to thebase.
 5. The device as claimed in claim 1, further comprising a trayhaving a bottom receptacle for receiving the receiving tube, first andsecond portions connected to one another through a hinge and a roundedside edge, spaced apart from the base.
 6. The device as claimed in claim5, wherein the tray comprises a wedged rim attached to the base.
 7. Thedevice as claimed in claim 5, further comprising a cover configured toencompass the receiving tube between the tray and the cover.
 8. Thedevice as claimed in claim 5, wherein the second portion of the traycomprises a notch substantially shaped as an inverted “V”, and situatedsubstantially coaxially with the longitudinal axis of the receivingtube.
 9. The device as claimed in claim 2, wherein the funnel comprisesat least two spaced apart walls defining a gap therebetween configuredto receive the flexible material part, the gap having a width less thanthe width of the distal opening of the receiving tube.
 10. The device asclaimed in claim 2, further comprising a tray having a bottom receptaclefor receiving the receiving tube and a rounded side edge, spaced apartfrom the base.
 11. The device as claimed in claim 3, further comprisinga tray having a bottom receptacle for receiving the receiving tube and arounded side edge, spaced apart from the base.
 12. The device as claimedin claim 4, further comprising a tray having a bottom receptacle forreceiving the receiving tube and a rounded side edge, spaced apart fromthe base.
 13. The device as claimed in claim 5, further comprising acover configured to encompass the receiving tube between the tray andthe cover.
 14. The device as claimed in claim 6, wherein the secondportion of the tray comprises a notch substantially shaped as aninverted “V”, and situated substantially coaxially with the longitudinalaxis of the receiving tube.
 15. The device as claimed in claim 7,wherein the second portion of the tray comprises a notch substantiallyshaped as an inverted “V”, and situated substantially coaxially with thelongitudinal axis of the receiving tube.
 16. The device as claimed inclaim 5, wherein the cover comprises a first section and a secondsection, the second section having a notch substantially shaped as aninverted “V” and situated substantially coaxially with the longitudinalaxis of the receiving tube.
 17. The device as claimed in claim 6,wherein the cover comprises a first section and a second section, thesecond section having a notch substantially shaped as an inverted “V”and situated substantially coaxially with the longitudinal axis of thereceiving tube.
 18. The device as claimed in claim 7, wherein the covercomprises a first section and a second section, the second sectionhaving a notch substantially shaped as an inverted “V” and situatedsubstantially coaxially with the longitudinal axis of the receivingtube.
 19. The device as claimed in claim 6, wherein the cover and thetray form a notch substantially shaped as an inverted “V”, and situatedsubstantially coaxially with the longitudinal axis of the receivingtube.
 20. The device as claimed in claim 7, wherein the cover and thetray form a notch substantially shaped as an inverted “V”, and situatedsubstantially coaxially with the longitudinal axis of the receivingtube.